Product Code: JAO
FDA class 2
21 CFR 892.1220
Scanner, Fluorescent
Radiology
A fluorescent scanner is a nuclear medicine imaging device that uses X-ray fluorescence excitation to detect and map the distribution of specific elements within tissues or materials, used in specialized diagnostic applications such as bone mineral analysis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JAO, regulated under 21 CFR 892.1220, within the Radiology medical specialty. This device is eligible for third-party review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
1
Basic Information
- Product Code
- JAO
- Device Class
- FDA class 2
- Regulation Number
- 892.1220
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.